Unicycive Therapeutics Inc (UNCY) Quote

RMB Ah yes the poutine industry :--)
Re market due for profit taking . I think at this time of year the risk for UNCY is more the harvesting of loss's for tax write offs . Profit taking ( and the tax consequences ) seem less of a risk ....JMO
Re nervous about the market ...always a good sign . Whenever one is confident theres no risk ...is when theres the most risk

I added to UNCY this am . Not suggesting anyone do likewise .
I think the video link I posted the other day was very interesting as it showed the interviewer ( Dr Topf ) recognizing the significance of IIRC 91% in the trial getting to serum pho goal ...plus his interest in UNI -494 re Acute Kidney injury / delayed graph function .

I think the FDA has granted them Orphan drug designation for delayed graph function . Delayed graph function is a real risk in kidney transplants where the new kidney is slow to start working or begins to fail .
UNI-494 appears to reduce that risk

But high risk spec . Will feel better if / when they get the PPS over $1 for 10 days and remove the R/S risk
Kiwi

Thanks for posting Kiwi. Rather positive for our little UNCY.
UNCY to be involved in two other conferences next week:
https://charts.stocktwits-cdn.com/production/original_594030670.jpg

On other news, I am beginning to get nervous. Just as things were looking very good for my small bios, with a typically good month or two for small caps coming up, I am now concerned that the overall market, which is due for at least some profit-taking, might take a real dump.

News this afternoon about across the board tariffs on Mexico and Canada starting Jan. 20. This kind of stuff spooks the market, generally. Only positive, would be for the fledgling American poutine industry.

My first thought was whether this would violate the USMCA, which was signed 6 years ago, after tearing up the NAFTA agreement. I can't get away with not paying a parking ticket.

Following Kidney Wk
Medical Research Analyst positive
The clinical trial results for OLC represent significant progress in treating hyperphosphatemia in CKD patients on dialysis. The 90% success rate in achieving phosphate control with OLC, particularly with 69% of patients requiring ≤1500/day, demonstrates strong efficacy. The favorable safety profile and recent NDA submission position OLC well for potential FDA approval.

The combination study of OLC with tenapanor showing synergistic effects (3.3x greater than tenapanor alone) suggests potential for enhanced treatment options. The Phase 1 results for UNI-494 also show promise, with therapeutic levels achieved and good safety profile, setting the stage for Phase 2 trials in kidney injury prevention.


Market Research Analyst positive
This comprehensive data presentation strengthens Unicycive's market position in the nephrology space. With an NDA submitted for OLC and positive Phase 1 results for UNI-494, the company is advancing two potentially valuable assets. The hyperphosphatemia market represents a significant opportunity, as millions of CKD patients on dialysis require phosphate control. The demonstrated efficacy and lower dosing requirements could provide competitive advantages over existing treatments.

The successful development of both products could significantly impact the company's 38.27M market cap, particularly if OLC receives FDA approval. The positive reception at ASN Kidney Week adds credibility to their clinical development program.

Kiwi

I think it may be hard to pull forward scripts of Xphozah since pharmacies may only dispense 1 mth at a time .
This is a problem my wife runs into with her dialysis patients . Many want pharmacies to dispense 3 mth scripts of various drugs so as to get a discount and also for convenience but the pharmacies often refuse and allow only 1 mth fills.
ARDX says if the Kidney Patient Act doesnt pass this yr they will provide Xphozah free to Medicare patients for the first 2 mths in 2025 ....meanwhile theres a major patient advocate movement underway to sort this mess out to enable continued access .

I agree that UNCY is less effected ...but will also be a winner if any deal or delay is worked out re new Oral pho drugs and the dialysis bindle

Kiwi

Not to be contrarian but I actually expect a big pull forward in Q4 for Xphozah. Wouldn't surprise me to see Ardx kill it in that quarter and post monster results.

I have, however, transitioned most of my kidney money to UNCY as I think they'll be less affected by the bundling. I actually wanted a flush under 50 cents to finish averaging down

From the recent kidney conference .
Interviewer starts off poorly prepared but recovers


Kiwi

Yes There will be less of a reaction in the UNCY stock for the reason you mentioned
ARDX is saying they will supply Xphozah free of charge to Medicare patients who lose coverage in Jan ...for the first 2 mths only
Nephrologists are probably already pulling back from starting Medicare patients on Xphozah if they think access to the drug is uncertain in Jan .
So biggest reaction will be in ARDx's stock if the Kidney Patient Act pass's before Jan 1st .......but that may still be a long shot despite the effort they are making now
Kiwi

Do you think, assuming the Kidney Act, that there would be less of a reaction in UNCY's stock price compared to ARDX's since UNCY won't receive approval for another 6 months or so?

UNCY will benefit if the Kidney Patient Act pass's ...new push in Congress

https://higherlogicdownload.s3.amazonaws.com/NRAA/8eb5e347-a0f4-4216-aac1-f22e0d697983/UploadedImages/Content/2024/RHA_Advocates_to_Protect_Access_to_Phosphate-Lowering_Therapies_11_21_24.pdf

Kiwi

Benchmark analyst Bruce Jackson reiterates Unicycive Therapeutics (NASDAQ:UNCY) with a Speculative Buy and maintains $3 price target.
9:38 AM EST, November 22, 2024 (Benzinga Newswire)
Write to Benzinga at editorial@benzinga.com

Well as contrarian sentiment indicators go ...this is me at my most bearish recently
Whalatane
11/14/24 10:24 AM
#543 RE: ErnieBilco #542
So a reverse split seems inevitable ?
I sold most of my position when the stock sold off after the FDA accepted the NDA...PPS acted the opposite to what I expected .
IMHO the only thing that saves this Co is passage of the Kidney Patient Act ...and thats no sure thing
Good luck
Kiwi

Been up since this post ..:--) forcing me to buy back what I sold :--(

Vivo Capital still report owning 9.99% of the outstanding shares

Kiwi

Looks like the market agrees with you . Good PPS action lately
Kiwi

You beat me to the punch Kiwi, as I was making dinner when I read Mr. Mister's post. This was pretty easy to verify. Hoping we can get more representatives on board asap. I have written to mine. Even tried writing to my old one in Florida. Not sure if you saw the other bill I was interested got passed in the House this past week and is awaiting action in the Senate. It had over 200 sponsors. The one eliminating the WEP and GPO for SS.

https://www.congress.gov/bill/118th-congress/house-bill/5074/cosponsors

Now 41 cosponsors /. Apparently 50 co sponsors is the tipping pt ( more likely vs less likely to pass ....not guaranteed )

My guess is the PPS of ARDX and UNCY will track the progress in getting more co sponsors by EOY .
Insider at ARDX just made a large insider purchase

Kiwi

Thanks for the note though I wonder how trustworthy this guy actually is. Several weeks ago, he posted about a large wall street bank predicting $ARDX would win its lawsuit against CMS.

Well, we all know how that turned out.

From Frank on X re Kidney Patient Act
$ARDX H.R.5074 added two more co-sponsors yday
-Rep. Hayes, Jahana [D-CT-5] 11/14/2024
-Rep. Pingree, Chellie [D-ME-1] 11/14/2024

Kiwi

That could very well be the case, but personally I'm expecting the pricing to come tomorrow, hope I'm wrong.

That would make sense

I could be wrong or the company could be lying but I think they just prepared the shelf to be able to sell shares on any PDUFA run up, which would make smart financial sense (and cents)

What a difference a day makes huh?

Yesterday they said this in their earnings report:

The Company believes that it has sufficient resources to fund planned operations into 2026.

So a reverse split seems inevitable ?
I sold most of my position when the stock sold off after the FDA accepted the NDA...PPS acted the opposite to what I expected .
IMHO the only thing that saves this Co is passage of the Kidney Patient Act ...and thats no sure thing
Good luck
Kiwi

S-3 out now it's just a waiting game to see where they price it.

I may see my 20s sooner than later - Vamos a ver lo que paso aqui

https://archive.fast-edgar.com/20241113/AL2ZG22CZ22CETLA22232ZO2H4O5ZZ22Z262/

A 13G just came online

Mr Mister. I need to correct the following the dialysis provider will be paid $34 per dialysis . On rereading it's $34 a mth .
My understanding is OLC would be covered under TDAPA for the first 2 yrs , then become part of the dialysis bundle which pays a total of $273 per dialysis ( including the pho binder ) plus $34 a mth to store , distribute pho binders .

The Kidney Patient Act needs to pass to ensure better coverage for the new oral pho binders once TDAPA ends

Kiwi

Mr Mister. It's difficult to get accurate prices for these drugs as copays , coupons , insurance plans etc vary so much .
As an example https://www.goodrx.com/fosrenol
My wife prescribes generic Fosrenol to her patients that refuse generic Renvela ...and says the best deal they can get is around $143 a mth ie the Good Rx price

When Fosrenol is included in the dialysis bundle the dialysis provider will be paid $34 per dialysis for the dialysis provider to buy , store and dispense Fosrenol .
Patients receive 12 dialysis sessions per month so $34 x 12 = $408 a month to cover purchase , storage , dispense etc
So dialysis providers should be able to negotiate bulk prices better then the best Good Rx price to purchase Fosrenol , control their storage costs etc and still have $ left over .
So the patient may now be paying LESS for generic Fosrenol .

OLC is a new version of Fosrenol
A similar Good Rx price for OLC may be in the low $200 range but will mean the dialysis provider will still make $60 - $100 + less per patient per month .
So they have the financial incentive to push the generic Fosrenol instead of the new OLC unless they can get the patient to pay more .

The numbers above are just my best guesstimates as prices are all over the place .

TDAPA is just the 2 yr introduction period and guarantees coverage .....but once ended and these new serum pho binders are in the dialysis bundles ...dialysis providers are financially incentivized to prescribe the generics .

The new CMS policy kills any new innovation in this drug space ......which is why patient advocate groups are so against it .

Kiwi

Thanks for your perspective. I had hoped and thought you suggested UNCY would price their compound so low as to be useful even if bundled.

Would applying for TDAPA help?

Mr Mister. I haven't communicated with IR but I think their problem is bigger than R/S etc .
Its wether ...under the new CMS / dialysis bundle rules ...they will even have much of a market once they launch OLC .

Currently as it stands , dialysis providers are unlikely to want to OK scripts for the new pho lowering drugs Xphozah and OLC because they will lose $ doing so .
Thats the stark reality unless the Kidney patient Act pass's

From memory ....CMS has approved an extra $34 per dialysis for managing / providing 2 serum pho binders ..Renvela and Fosrenol ( both generic )
So each week the providers get around $102 per patient to cover these drugs ...patients are dialyzed 3 times a week
Renvela can cost as low as $9 a day ...so $63 a week ...dialysis provider makes $ or at least breakeven
Probably buys at huge discounts ...so very likely to make $

Fosrenol costs more and is the back up if patients can't tolerate Renvela ....but providers can probably break even on it or maybe get the patient to pay a small copay

Dialysis providers will lose $ prescribing OLC and lose a lot prescribing Xphozah ......if the only way these drugs are paid for is out of the dialysis payment bundle ( $273 per dialysis plus $34 for the serum pho binder )

If patients had to pay for the new serum pho drugs themselves ...assuming their insurance policies would cover
The Medicare patients can't use any company coupons so would be paying roughly 20% of the cost each month ( as a copay ) , which would be over $600 a mth for Xphozah and around $200 a month for OLC
Medicare patients won't make those payments ...they are over 65 , usually with limited incomes

The above numbers are guesstimates . Different medical plans , rebates etc make it difficult to get accurate numbers but in general, the way its currently stands ....UNCY is facing a huge marketing challenge once they launch .....UNLESS the Kidney Patient Act pass's

JMO
Kiwi

Has anyone reached out to UNCY investor relations to see how they plan to meet minimum listing standards or prevent a R/S?

I've talked to them and got responses about other issues but none concerning this. Maybe an investor with more shares than me would get a response....

RMB. My wild guess is that it's now mainly about how to fund the launch in 2025 .
I had expected them to do a capital raise on FDA approval , and to focus on getting the PPS over $1 before then to keep Naz compliance .
Now I'm not so sure .
Mkt may be pricing in a capital raise and reverse split in our near future .
I had read some concerns about their patents ... but either way I think they have market exclusivity ( new drug ) for a certain number of years ....not sure if it's greater than the 3 yr mentioned below . I had read they qualify for longer exclusivity but can't find that text ...it might be in an earnings report Q&A

Three-Year Clinical Investigation Exclusivity
The most common type of exclusivity granted to new formulations is the three-year clinical investigation exclusivity (CIE)13. This applies when:
The application includes reports of new clinical investigations (other than bioavailability studies)
The studies were essential to approval
The studies were conducted or sponsored by the applicant
This exclusivity blocks approval of competitor's 505(b)(2) or ANDA applications for the same product modification for three years, but does not prevent their submission3.

So the Co that sells Fosrenol ( Lanthanum ) could roughly copy what UNCY did and have a competing similar product in about 4 yrs ( includes time to develop and run a trial with dialysis patients )...???

Kiwi

I guess those betting on acceptance had all piled in before today, so no more buying pressure. Have to see how the next few days shake out.  

Thx for the link ......and currently down 6% on the news ?? surprise to me .
Co says they plan to launch after approval in 2025 . They will need funding for that so I guess the mkt is factoring in a capital raise sooner or later .
If sooner a reverse split seems inevitable unless they sell their other asset .
Passage of the Kidney patient Act ...if it happens ...will definitely help
ARDX downgraded today
Kiwi

Other than passage of the Kidney Act I should say. 

I guess this acceptance was built-in by the rise from 25 cents to 60 cents.  Not sure what other catalyst can get us to a buck?

Thanks for posting.  Saw that a few min ago.  However it doesn't yet seem to be moving the stock in pm yet.  News not reached enough people?   

https://www.globenewswire.com/news-release/2024/11/11/2978178/0/en/Unicycive-Therapeutics-Announces-U-S-FDA-Acceptance-of-the-New-Drug-Application-NDA-for-Oxylanthanum-Carbonate-OLC-for-the-Treatment-of-Hyperphosphatemia-in-Patients-with-Chronic-K.html

looks like Ardelyx may have some actual competition next year

Thanks for posting.  The more pressure put on Congress the better chance (never great) that the Kidney Act gets passed.  All it takes though is someone with a wild hair up their arse to block the thing. 

Happened to me this past week.  The House was set to vote on eliminating WEP for SS, and 2 from the Freedom Caucus put a block.  Last I heard, upset so many that Johnson promises to bring it to a vote this week. Shall see. 

https://kidneycarepartners.org/press/kidney-care-partners-supports-policies-to-expand-home-dialysis-and-improve-reimbursement-for-phosphate-lowering-drugs-remains-concerned-cms-has-not-addressed-barriers-to-patient-access-to-innovative/

Kiwi

Also beginning Jan. 1, 2025, the bundled payment will include oral-only renal dialysis drugs and biologics — a move initially set to begin in 2014 but delayed until now by several laws and court challenges.

“In response to comments that we received on the proposed rule [released in July], we are finalizing a policy to pay the [transitional drug add-on payment adjustment] for phosphate binders based on 100% of the average sales price, increased by a fixed amount of $36.41 for incremental costs such as dispensing and storage of phosphate binders, which will be added to any monthly claim for which there is a [transitional drug add-on payment adjustment] payment for phosphate binders. We expect that incorporating oral-only drugs and biological products into the [End-stage Renal Disease Prospective Payment System] will increase access to these drugs,” CMS stated in the release.

In a response statement, Kidney Care Partners (KPC), a non-profit coalition of stakeholder organizations, expressed concern that “the base rate is insufficient to support adding new treatment options without adding new money.”

“We applaud CMS’s efforts both in recognizing that providing oral-only medications as part of the bundle requires additional funding, as well as creating access for AKI patients to home dialysis,” Mahesh Krishnan, MD, MPH, MBA, chair of Kidney Care Partners, said in the statement. “However, KCP has consistently raised concerns that significant changes are needed to the ESRD PPS system to maintain an appropriate level of care, access and reimbursement for the more than 557,000 Americans who rely on regular dialysis treatment.”

KPC urged support of the Chronic Kidney Disease Improvement in Research and Treatment Act of 2023 (H.R. 5027/S. 4469) to provide a permanent reimbursement pathway for innovative drugs and devices.

Kiwi

I guess we are good.  But never sure in this bizarro world.  

Well I've bitten my finger nails down to my elbow:--) It will now be a real surprise to me if their NDA is rejected ...assuming we hear nothing by 6 pm ET

Kiwi

About how many is plenty? lol

Good luck to us all.  I have plenty right now.  

From Dew on the Biotech Values board
The FDA usually accepts an NDA/BLA for filing during the 60-75 day window.

My read is that denial must be within 60 days with the Co having up to 4 days to PR decision
Times up today

Kiwi

Buying more UNCY ...what the F

Not investment advice etc etc

Kiwi

All that matters today ...is no denial letter

Kiwi

Great work Kiwi.  Sort of jives with the Nov 14 or 16 date.  Now we just have to hope for radio silence from UNCY this weekend. Tape their mouths shut.  

Why do you think the bad news for ARDX is not spilling over to UNCY?

RMB.
If accepted, the FDA will send a "Day 74 letter" (74 days from the original NDA submission) containing the planned review timeline1.

Not super clear on this ( nothing new :--) ) but it appears that if the Co does not post a denial letter by end of today ...the application has been accepted and we await the 74 day letter

Kiwi

The FDA typically notifies an applicant about the approval status of a New Drug Application (NDA) through the following process:

Within 60 days of receiving the NDA submission, the FDA will determine whether to accept the application for filing and review13.

If accepted, the FDA will send a "Day 74 letter" (74 days from the original NDA submission) containing the planned review timeline1.

The FDA then conducts a thorough review of the application. The standard review time is 10 months from the date of filing for most NDAs1.

Kiwi

Kiwi, you are giving us a glimmer of hope if there is a possibility of a longer time frame for notice if approved.  Maybe that is why the stock has firmed up more this week with the realization that there won't be a denial.  Let us know if you find approval yields a longer time frame.  Not sure what a poster I read on yahoo was referring to but their contention that Nov 16 could be the expected date, so not sure if that has any merit.